Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps

Pain, Postoperative Clinical Trial

— Acute pain  

Official title:

Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis: A Multicenter Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04115904
• Other study ID #: 2019
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: February 8, 2018
• Est. completion date: September 28, 2019

Study information

• Verified date: October 2019
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim to compare acute pain rate after single-visit ortwo-visits treatment of teeth with necrotic pulp and apical periodontitis .90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with acute postoperative pain.

Description:

90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. M4system with Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with severe postoperative pain and/orswelling were classified as acute pain.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: September 28, 2019
• Est. primary completion date: September 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: a) Radiographic evidence of apical periodontitis (minimum size =2.0mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negativeresponse to hot and cold tests and b) Need for retreatment. Thermal pulptesting was performed by the author, and radiographic interpretation wasverified by one certified oral surgeon

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Exclusion Criteria:

• patients without inclusion requirements or failure to obtain patient ´sauthorization. Patients, were excluded if they were younger than 18 yearsold, pregnant, had a positive history of antibiotic use within the past month,suffered from diabetes, or other systemic diseases. Teeth with periodontalpockets deeper than 4 mm also were excluded of the study

Related Conditions & MeSH terms

• Acute Pain
• Dental Pulp Necrosis
• Pain, Postoperative

Intervention

Procedure:
• Ibuprofen for post operative pain
All treatment sessions were approximately 45 minutes in length to allow for acceptable time for completionof treatment and retreatment in one or two visits. Allthe clinical procedures were performed by the author.Following local anesthesia with 2% lidocaine with1:100,000 epinephrine (Septodont Saint-Maur desFossés, France) and rubber dam isolation the toothwas disinfected with 5.25% NaOCl (Ultra bleach,Bentonville, AR, USA).

Locations

Country	Name	City	State
Mexico	Jorge Paredes Vieyra	Tijuana	Baja California
Mexico	Jorge Paredes Vieyra	Tijuana	Baja Califronia
Mexico	Jose Clemente	Tijuana	BC
Mexico	Jose Clemente Orozco	Tijuana	BC

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measure with general pain scale	Each patient will recall a week to evaluate post operative pain	a week